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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 62670
Product Type Biologics
Status Ongoing
Recalling Firm Genzyme Corporation
City Framingham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Genzyme Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)], 25 mg, for intravenous use only, Rx. NDC 58468-0080-01 C0072C01 Feb 2013; C0062C01 Dec 2012; C0086C01 May 2013; C0094C01 Jul 2013; C0096C01 Aug 2013; C0098C01 Aug 2013; C0098C02 Aug 2013; C0098C03 Aug 2013; C0100C01 Aug-2013 Class II Anti-Thymocyte Globulin (Rabbit) 25 mg, with an OOS assay result on the molecular size distribution stability test, was distributed. 9 units B-0964-13